BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSYN 0 VL 60 GS-25 LOOP

    MDR report key: 2978454 · Received February 22, 2013

    Report

    Report Number
    1219930-2013-00099
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    COVIDIEN, FORMERLY US
    Product Code
    GAM
    PMA / PMN Number
    K000037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGICAL. ACCORDING TO THE REPORTER: WHILE SUTURING THE FASCIA, THE NEEDLE BROKE AT THE SWAGE. THE PATIENT WAS EXAMINED BY X-RAY AND IT WA CONFIRMED NOTHING FELL INTO CAVITY. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO UNANTICIPATED TISSUE LOSS. PATIENT IS UNDER OBSERVATION. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78269 BIOSYN 0 VL 60 GS-25 LOOP BIOSYN GAM COVIDIEN, FORMERLY US B2H099X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other